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Sponsor study identifier
Secondary identifiers
observational
5,444
1 country
1
Study Start
January 27, 2010
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
Not reported
Date not reportedStudy Completion
March 17, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Background: \- National Cancer Institute Protocol 04-C-N191, also known as the Costa Rica Vaccine Trial, was a double-blind controlled study of the effectiveness of an experimental human papillomavirus (HPV) vaccine in preventing cervical cancer in young women in Costa Rica. Costa Rica was part of the first large study to show the association between HPV and cervical cancer, and the study contributed greatly to the understanding of this association. The women who have participated in the vaccine trial in Costa Rica are reaching the end of the follow-up period offered in the vaccine trial protocol, and as a result they are being offered the chance to have complementary vaccinations against HPV, hepatitis A, and hepatitis B. Objectives:
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 17, 2015
Date type not reportedThis date has not been verified as actual or estimated.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 27, 2010
Date type not reportedThis date has not been verified as actual or estimated.
March 12, 2010
Actual (reported)March 15, 2010
Actual (reported)March 17, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Proyecto Epidemiologico Guanaste (PEG)
San José, Costa Rica
Reeves WC, Brinton LA, Garcia M, Brenes MM, Herrero R, Gaitan E, Tenorio F, de Britton RC, Rawls WE. Human papillomavirus infection and cervical cancer in Latin America. N Engl J Med. 1989 Jun 1;320(22):1437-41. doi: 10.1056/NEJM198906013202201.
Herrero R, Brinton LA, Reeves WC, Brenes MM, Tenorio F, de Britton RC, Gaitan E, Garcia M, Rawls WE. Invasive cervical cancer and smoking in Latin America. J Natl Cancer Inst. 1989 Feb 1;81(3):205-11. doi: 10.1093/jnci/81.3.205.
Allan Hildesheim, Ph.D.
National Cancer Institute (NCI)
5,444 participants (actual enrollment reported by the registry).
First Submitted
March 12, 2010
First Posted
March 15, 2010
Study Start
January 27, 2010
Date type not reportedThis date has not been verified as actual or estimated.
Contact the study team to confirm eligibility.
Herrero R, Schiffman MH, Bratti C, Hildesheim A, Balmaceda I, Sherman ME, Greenberg M, Cardenas F, Gomez V, Helgesen K, Morales J, Hutchinson M, Mango L, Alfaro M, Potischman NW, Wacholder S, Swanson C, Brinton LA. Design and methods of a population-based natural history study of cervical neoplasia in a rural province of Costa Rica: the Guanacaste Project. Rev Panam Salud Publica. 1997 May;1(5):362-75. doi: 10.1590/s1020-49891997000500005.
Panagiotou OA, Befano BL, Gonzalez P, Rodriguez AC, Herrero R, Schiller JT, Kreimer AR, Schiffman M, Hildesheim A, Wilcox AJ, Wacholder S; Costa Rica HPV Vaccine Trial (CVT) Group (see end of manuscript for full list of investigators). Effect of bivalent human papillomavirus vaccination on pregnancy outcomes: long term observational follow-up in the Costa Rica HPV Vaccine Trial. BMJ. 2015 Sep 7;351:h4358. doi: 10.1136/bmj.h4358.
Study Completion
March 17, 2015
Date type not reportedThis date has not been verified as actual or estimated.
Last Updated
April 5, 2018
Record last verified: 2015-03-17
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Source: ClinicalTrials.gov.
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